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oai:repisalud.isciii.es:20.500.12105/155082024-09-21T10:51:56Zcom_20.500.12105_19604com_20.500.12105_2051col_20.500.12105_19605

00925njm 22002777a 4500 dc Li, Guoping author Chen, Tianji author Dahlman, James author Eniola-Adefeso, Lola author Ghiran, Ionita C author Kurre, Peter author Lam, Wilbur A author Lang, Jennifer K author Marbán, Eduardo author Martín, Pilar author Momma, Stefan author Moos, Malcolm author Nelson, Deborah J author Raffai, Robert L author Ren, Xi author Sluijter, Joost P G author Stott, Shannon L author Vunjak-Novakovic, Gordana author Walker, Nykia D author Wang, Zhenjia author Witwer, Kenneth W author Yang, Phillip C author Lundberg, Martha S author Ochocinska, Margaret J author Wong, Renee author Zhou, Guofei author Chan, Stephen Y author Das, Saumta author Sundd, Prithu author 2023-02 Extracellular vesicles (EVs) carry diverse bioactive components including nucleic acids, proteins, lipids and metabolites that play versatile roles in intercellular and interorgan communication. The capability to modulate their stability, tissue-specific targeting and cargo render EVs as promising nanotherapeutics for treating heart, lung, blood and sleep (HLBS) diseases. However, current limitations in large-scale manufacturing of therapeutic-grade EVs, and knowledge gaps in EV biogenesis and heterogeneity pose significant challenges in their clinical application as diagnostics or therapeutics for HLBS diseases. To address these challenges, a strategic workshop with multidisciplinary experts in EV biology and U.S. Food and Drug Administration (USFDA) officials was convened by the National Heart, Lung and Blood Institute. The presentations and discussions were focused on summarizing the current state of science and technology for engineering therapeutic EVs for HLBS diseases, identifying critical knowledge gaps and regulatory challenges and suggesting potential solutions to promulgate translation of therapeutic EVs to the clinic. Benchmarks to meet the critical quality attributes set by the USFDA for other cell-based therapeutics were discussed. Development of novel strategies and approaches for scaling-up EV production and the quality control/quality analysis (QC/QA) of EV-based therapeutics were recognized as the necessary milestones for future investigations. J Extracell Vesicles . 2023 Feb;12(2):e12305 http://hdl.handle.net/20.500.12105/15508 36775986 10.1002/jev2.12305 2001-3078 Journal of extracellular vesicles Current challenges and future directions for engineering extracellular vesicles for heart, lung, blood and sleep diseases.